an extension study of laq/5062 exploring the long term safety, tolerability and clinical effect parameters during the disease

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: this is a multinational, multicenter, randomized, double-blind, parallel-group active extension of laq/5062 study (nct00349193), assessing the tolerability, safety and efficacy of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in participants with relapsing remitting multiple sclerosis (rrms), followed by an open-label phase of laquinimod 0.6 mg daily. this study is laq/5063 (i.e., double-blind extension) and laq/5063 ol (i.e., subsequent open-label extension). - the first period of the extension study is an active, double-blind period. participants from the active treatment arms in laq/5062 continue their assigned treatment in blinded fashion. participants who were assigned to placebo treatment in laq/5062 are equally randomized in blinded-fashion to laquinimod 0.6 mg or laquinimod 0.3 mg. - once termination visit of laq/5063 active double-blind phase (completion of the full 36 weeks or as requested by the sponsor) is performed, all participants continue on laquinimod 0.6 mg daily as an open-label intervention. the open-label period continues as long as the sponsor continues the development of laquinimod 0.6 mg for rrms or early discontinuation.


Eligibility criteria:
inclusion criteria - participants must have completed the 36 weeks of treatment (completion of the full 36 weeks or as requested by the sponsor) of the active double-blind phase. - women of childbearing potential (for example, women who were not postmenopausal or surgically sterilized) must have practiced 2 acceptable methods of birth control for the duration of the study and until 30 days after the last dose of study medication (acceptable methods of birth control in this open-label extension phase included intrauterine devices, barrier methods \[condom or diaphragm with spermicide\], and hormonal methods of birth control \[for example, oral contraceptive, contraceptive patch, and long-acting injectable contraceptive\]). - participants must have been willing and able to comply with the protocol requirements for the duration of laq/5063 ol. - participants must have given signed, written informed consent prior to entering laq/5063 ol. - for the 36 months further extension: participants must have completed the 24 months of treatment of the first period of the open label phase. exclusion criteria - for the 36 month further extension: premature discontinuation from laq/5063 ol phase prior to completion of 24 months of treatment period. - pregnancy or breastfeeding. - participants with clinically significant or unstable medical or surgical condition, detected or worsened during the active double-blind phase of laq/5063, which would have precluded safe and complete study participation. - use of experimental drugs, immunosuppressive drugs, and/or participation in clinical studies within the period from termination of laq/5063 active double-blind phase to laq/5063 ol. - previous treatment with immunomodulators with the exception of laquinimod (including interferon \[ifn\] 1a and 1b, glatiramer acetate, and intravenous \[iv\] immunoglobulin) within 2 months prior to entering the open-label phase for those subjects who had a time gap between termination of laq/5063 active double-blind phase to laq/5063 ol. - use of corticosteroids within 30 days prior to entering the open-label phase, except for iv methylprednisolone 1 grams/day for a maximum of 3 days, in the period from termination of laq/5063 active double-blind phase to laq/5063 ol. - use of potent inhibitors of cytochrome p3a4 (cyp3a4) within 2 weeks prior to laq/5063 ol and/or use of fluoxetine 1 month prior to entering laq/5063 ol, in the period from termination of laq/5063 active double-blind phase to laq/5063 ol. - use of the following substrates of cytochrome p1a2 (cyp1a2): theophylline and/or warfarin within 2 weeks prior to entering laq/5063 ol, in the period from termination of laq/5063 active double-blind phase to laq/5063 ol. - use of amiodarone in the period from termination of laq/5063 active double-blind phase to laq/5063 ol. - following the switch to new formulation (capsules), hypersensitivity to mannitol, meglumine, or sodium stearyl fumarate.